[Federal Register: April 26, 2000 (Volume 65, Number 81)]
[Notices]
[Page 24489]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap00-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting is
open to the public.
Name of Committee: Endocrinologic and Metabolic Drugs Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on May 19, 2000, 10 a.m.
to 2 p.m.
Location: Holiday Inn, Ballroom, 8120 Wisconsin Ave., Bethesda,
MD.
Contact Person: Kathleen R. Reedy or LaNise S. Giles, Center for
Drug Evaluation and Research (HFD-21), Food and Drug Administration,
5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm.
1093), Rockville MD, 301-827-7001, email: reedyk@cder.fda.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 12536. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committee will hear a presentation of the data and
rationale for the regulatory action regarding the withdrawal from
the U.S. market of RezulinTM (troglitazone, Parke-Davis
Pharmaceutical Research, a Division of Warner-Lambert) for the
treatment of type 2 diabetes mellitus.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by May 15,
2000. Oral presentations from the public will be scheduled between
approximately 10 a.m. and 11 a.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before May 15, 2000,
and submit a brief statement of the general nature of the evidence
or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time
requested to make their presentation.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 17, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-10321 Filed 4-25-00; 8:45 am]
BILLING CODE 4160-01-F